Part 862 Subpart C—Clinical Laboratory Instruments
FDA submissions for Part 862 Subpart C—Clinical Laboratory Instruments in the Clinical Chemistry (CH) review panel, including product codes and regulations.
Section range: §§ 862.2050–862.2920
CFR Part: 862
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| GLE | Mixer, Blood Tube | 862.2050 | 1 | 5 |
| JBS | Timer, General Laboratory | 862.2050 | 1 | 0 |
| JJP | Electrode, Ion Selective (Non-Specified) | 862.2050 | 1 | 3 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 862.2050 | 1 | 38 |
| JQO | Balance, Analytical | 862.2050 | 1 | 0 |
| JQQ | Dialyzer | 862.2050 | 1 | 1 |
| JQY | Ph Meter | 862.2050 | 1 | 8 |
| JQZ | Polarimeter | 862.2050 | 1 | 1 |
| JRB | Micro Mixer | 862.2050 | 1 | 0 |
| JRC | Micro Pipette | 862.2050 | 1 | 6 |
| JRG | Block, Heating | 862.2050 | 1 | 3 |
| JRI | Cuvette, Thermostated | 862.2050 | 1 | 4 |
| JRJ | Unit, Drying | 862.2050 | 1 | 1 |
| JRK | Evaporator | 862.2050 | 1 | 0 |
| JRL | Unit, Filter, Membrane | 862.2050 | 1 | 9 |
| JRM | Freezer | 862.2050 | 1 | 7 |
| JRO | Blender/Mixer | 862.2050 | 1 | 0 |
| JRQ | Shaker/Stirrer | 862.2050 | 1 | 8 |
| JRR | Regulator, Temperature | 862.2050 | 1 | 4 |
| JRS | Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | 862.2050 | 1 | 0 |
| LCI | Automated Radioimmunoassay Systems, For Clinical Use | 862.2050 | 1 | 3 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 862.2050 | 1 | 3 |
| QBV | Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate | 862.2050 | 1 | 2 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 862.2100 | 1 | 78 |
| NVV | Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System | 862.2100 | 1 | 0 |
| PHV | Continuous Glucose Monitor Retrospective Data Analysis Software | 862.2120 | 1 | 1 |
| JJG | Analyzer, Chemistry, Centrifugal, For Clinical Use | 862.2140 | 1 | 30 |
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | 862.2150 | 1 | 32 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 862.2160 | 1 | 208 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 862.2170 | 1 | 57 |
| DJY | Ion-Exchange Chromatography | 862.2230 | 1 | 11 |
| DKO | Adsorbents, Ion-Exchange | 862.2230 | 1 | 1 |
| DMG | Papers, Ion | 862.2230 | 1 | 0 |
| KEA | Resins, Ion-Exchange | 862.2230 | 1 | 9 |
| DII | Columns, Glc | 862.2250 | 1 | 5 |
| DJA | Column Supports, Glc | 862.2250 | 1 | 1 |
| DLG | Coating, Liquid, Glc | 862.2250 | 1 | 7 |
| DMS | Gases, Glc | 862.2250 | 1 | 0 |
| JSQ | Chromatography For Bacterial Identification | 862.2250 | 1 | 3 |
| JXQ | Monitor, U.V., Glc | 862.2250 | 1 | 0 |
| KZQ | Chromatography(Gas), Clinical Use | 862.2250 | 1 | 12 |
| DMZ | Liquid Chromatography, Adsorbent | 862.2260 | 1 | 1 |
| DNH | Resins, Ion-Exchange, Liquid Chromatography | 862.2260 | 1 | 1 |
| DPM | Columns, Liquid Chromatography | 862.2260 | 1 | 16 |
| KIE | Apparatus, High Pressure Liquid Chromatography | 862.2260 | 1 | 25 |
| KZR | Chromatography (Liquid, Gel), Clinical Use | 862.2260 | 1 | 15 |
| LDM | Instrumentation, High Pressure Liquid Chromatography | 862.2260 | 1 | 19 |
| LEQ | Detectors, Electrochemical, Liquid Chromatography | 862.2260 | 1 | 4 |
| DJO | Indicator, Cellulose Fluorescent, Tlc | 862.2270 | 1 | 0 |
| DJS | U.V. Light, Tlc | 862.2270 | 1 | 1 |
| DKG | Plate, Cellulose, Tlc | 862.2270 | 1 | 1 |
| DKK | Tanks, Developing, Tlc | 862.2270 | 1 | 1 |
| DKS | Plate, Silica Gel, Tlc | 862.2270 | 1 | 0 |
| DKY | Indicator, Alumina Fluorescent, Tlc | 862.2270 | 1 | 0 |
| DLC | Atomizer, Tlc | 862.2270 | 1 | 0 |
| DLO | Indicator, Silica Gel Fluorescent, Tlc | 862.2270 | 1 | 0 |
| DLY | Plate, Alumina, Tlc | 862.2270 | 1 | 0 |
| DPA | Apparatus, General Use, Thin Layer Chromatography | 862.2270 | 1 | 5 |
| KZS | Chromatography (Thin Layer), Clinical Use | 862.2270 | 1 | 0 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 862.2300 | 1 | 258 |
| JJH | Clinical Sample Concentrator | 862.2310 | 1 | 15 |
| OUL | Thermocycler, Generic | 862.2310 | 1 | 0 |
| PEG | Nucleic Acid Quantitation Kit | 862.2310 | 1 | 0 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 862.2320 | 1 | 63 |
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | 862.2400 | 1 | 18 |
| JJN | Apparatus, Electrophoresis, For Clinical Use | 862.2485 | 1 | 34 |
| JJI | Analyzer, Enzyme, For Clinical Use | 862.2500 | 1 | 8 |
| JJO | Flame Emission Photometer For Clinical Use | 862.2540 | 1 | 22 |
| KHO | Fluorometer, For Clinical Use | 862.2560 | 1 | 38 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | 862.2570 | 2 | 13 |
| OOI | Real Time Nucleic Acid Amplification System | 862.2570 | 2 | 14 |
| OTA | Mass Spectrometer For Clinical Multiplex Test Systems | 862.2570 | 2 | 0 |
| OUE | Micro Total Analysis Instrument System | 862.2570 | 2 | 0 |
| OVA | Complete Gene Expression Profiling Accessory Reagents | 862.2570 | 2 | 1 |
| PCA | Dna Genetic Analyzer | 862.2570 | 2 | 1 |
| PHG | Droplet Digital Pcr System | 862.2570 | 2 | 0 |
| PQQ | Data Acquisition Software | 862.2570 | 2 | 0 |
| JRA | Microtitrator, For Clinical Use | 862.2680 | 1 | 1 |
| JQX | Nephelometer, For Clinical Use | 862.2700 | 1 | 14 |
| JJK | Oncometer, Plasma, For Clinical Use | 862.2720 | 1 | 4 |
| JJM | Osmometer For Clinical Use | 862.2730 | 1 | 12 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 862.2750 | 1 | 140 |
| PER | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | 862.2750 | 1 | 3 |
| QBZ | Automated Platform Consisting Of Software And Instrumentation For Pooling And/Or Lysing Donor Blood, Serum, Or Plasma | 862.2750 | 1 | 0 |
| JRE | Refractometer For Clinical Use | 862.2800 | 1 | 13 |
| PSM | Refractometer For Donor Testing | 862.2800 | 1 | 0 |
| JXR | Atomic Absorption Spectrophotometer, General Use | 862.2850 | 1 | 29 |
| DOP | Mass Spectrometer, Clinical Use | 862.2860 | 1 | 10 |
| KQO | Automated Urinalysis System | 862.2900 | 1 | 46 |
| JJL | Plasma Viscometer For Clinical Use | 862.2920 | 1 | 1 |
